Effectiveness of different cleaning agents for retainers
| ISRCTN | ISRCTN56234764 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56234764 |
- Submission date
- 19/10/2020
- Registration date
- 02/11/2020
- Last edited
- 18/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Current plain English summary as of 23/02/2022:
Background and study aims
After the completion of orthodontic treatment, patients undergo a retention phase to maintain the results. During this phase, an orthodontic retainer is used. The retainer is worn 24 hours a day except when eating, drinking, brushing and playing sports. Without adequate cleaning, retainers can accumulate plaque and bacteria, leading to gingival (gum) inflammation and disease. A study showed that saliva quantity and composition is affected during orthodontic treatment. A variety of alternative cleaning agents have been discussed of which were mostly tested on acrylic orthodontic appliances and prostheses. To date, however, few studies have been performed to investigate the effects of cleaning agents on thermoplastic retainers and changes in the oral environment. The aim of this study is to assess the effectiveness of different cleaning agents for retainers.
Who can participate?
Adults over the age of 18 who are fitted with a thermoplastic retainer
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group are asked to clean their retainers using tap water. Those in the second group are asked to clean using a provided toothpaste and the third group are asked to clean using Retainer Brite to clean their retainers. A detailed explanation, demonstration and written instructions will be provided. The study lasts 12 months in total. Participants saliva will be assessed during retainer fit and at 6 months and 12 months follow up. Participants also complete an assessment form during the 6 months and 12 months follow up appointment.
What are the possible benefits and risks of participating?
There is no risk of participating in this study as it is carried out during the regular follow up of treatment. The results of this study will benefit individuals, researchers, and the community with the advancement of knowledge and orthodontic practice. It will also show if the different cleaning agents influence saliva parameters and the patients’ experience. It will also be beneficial to practitioners to know the best cleaning agent with the least amount of bacteria which will support the recommendations for cleaning methods of orthodontic retainers in the future.
Where is the study run from?
Universiti Teknologi Mara (UiTM) (Malaysia)
When is the study starting and how long is it expected to run for?
September 2019 to December 2022
Who is funding the study?
Universiti Teknologi Mara (UiTM) (Malaysia)
Who is the main contact?
1. Dr Iman binti Azmuddin
imanazmuddin@gmail.com
2. Dr Saraswathy Devi Sinniah
saraswathy6153@uitm.edu.my
Previous plain English summary:
Background and study aims
After the completion of orthodontic treatment, patients undergo a retention phase to maintain the results. During this phase, an orthodontic retainer is used. The retainer is worn 24 hours a day except when eating, drinking, brushing and playing sports. Without adequate cleaning, retainers can accumulate plaque and bacteria, leading to gingival (gum) inflammation and disease. A study showed that saliva quantity and composition is affected during orthodontic treatment. A variety of alternative cleaning agents have been discussed of which were mostly tested on acrylic orthodontic appliances and prostheses. To date, however, few studies have been performed to investigate the effects of cleaning agents on thermoplastic retainers and changes in the oral environment. The aim of this study is to assess the effectiveness of different cleaning agents for retainers.
Who can participate?
Adults over the age of 18 who are fitted with a thermoplastic retainer
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group are asked to clean their retainers using tap water. Those in the second group are asked to clean using a provided toothpaste and the third group are asked to clean using Retainer Brite to clean their retainers. A detailed explanation, demonstration and written instructions will be provided. The study lasts 6 months in total. Participants saliva will be assessed during retainer fit and at 3 months and 6 months follow up. Participants also complete an assessment form during the 3 months and 6 months follow up appointment.
What are the possible benefits and risks of participating?
There is no risk of participating in this study as it is carried out during the regular follow up of treatment. The results of this study will benefit individuals, researchers, and the community with the advancement of knowledge and orthodontic practice. It will also show if the different cleaning agents influence saliva parameters and the patients’ experience. It will also be beneficial to practitioners to know the best cleaning agent with the least amount of bacteria which will support the recommendations for cleaning methods of orthodontic retainers in the future.
Where is the study run from?
Universiti Teknologi Mara (UiTM) (Malaysia)
When is the study starting and how long is it expected to run for?
September 2019 to February 2022 (updated 12/05/2021, previously: November 2021)
Who is funding the study?
Universiti Teknologi Mara (UiTM) (Malaysia)
Who is the main contact?
1. Dr Iman binti Azmuddin
imanazmuddin@gmail.com
2. Dr Saraswathy Devi Sinniah
saraswathy6153@uitm.edu.my
Contact information
Public
Faculty of Dentistry
Universiti Teknologi Mara (UiTM)
Sungai Buloh
47000
Malaysia
 ORCID ID |
0000-0002-2216-5047 |
|---|---|
| Phone | +60 (0)132580852 |
| imanazmuddin@gmail.com |
Scientific
Faculty of Dentistry
Universiti Teknologi Mara (UiTM)
Sungai Buloh
47000
Malaysia
| ORCID ID |
0000-0003-1481-2424 |
|---|---|
| Phone | +60 (0)361266100 |
| saraswathy6153@uitm.edu.my |
Scientific
Center of Paediatric Dentistry and Orthodontic Studies
Universiti Teknologi Mara (UiTM)
Sungai Buloh
47000
Malaysia
| ORCID ID |
0000-0002-6095-993X |
|---|---|
| nikmukhriz@uitm.edu.my |
Study information
| Study design | Single-center interventional single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness of thermoplastic retainer cleansing agents and patient-reported outcome: a randomized controlled trial |
| Study acronym | ETRCA |
| Study hypothesis | 1. There is no significant difference in the presence of Mutans Streptococci (MS) between three cleansing agents 2. There is no significant difference in salivary parameters in unstimulated saliva 3. There is no significant difference in patient-reported outcome with different cleansing agents |
| Ethics approval(s) | Approved 29/09/2020, UiTM Research Ethics Committee (Research Management Centre (RMC), Office of Deputy Vice Chancellor (Research & Innovation) Universiti Teknologi MARA, Level 3, Bangunan Wawasan, 40450 Shah Alam, Selangor, Malaysia; +60 (0)355442049; recsecretariat@uitm.edu.my), ref: 600- TNCP1(5/1/6) |
| Condition | Prevention of caries in patients wearing a thermoplastic retainer |
| Intervention | Current intervention as of 23/02/2022: This trial is a randomized controlled trial with three parallel arms. Patients will be randomly allocated to either group A (tap water), group B (toothpaste), or group C (Retainer Brite). The list of randomisation will be generated using SPSS statistical software. A detailed explanation, demonstration, and written instructions will be provided. The study lasts 12 months in total. Participants' saliva will be assessed during the retainer fitting and at 6 months and 12 months follow up. Participants also complete an assessment form during the 6 month and 12 month follow-up appointments. Previous intervention: This trial is a randomized controlled trial with three parallel arms. Patients will be randomly allocated to either group A (tap water), group B (toothpaste) or group C (Retainer Brite). The list of randomisation will be generated using SPSS statistical software. A detailed explanation, demonstration and written instructions will be provided. The study lasts 6 months in total. Participants saliva will be assessed during the retainer fitting and at 3 months and 6 months follow up. Participants also complete an assessment form during the 3 months and 6 months follow up appointment. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 23/02/2022: Bacterial count of Mutans Streptococci (MS) measured using colony counting method at retainer fit, 6, and 12 months post retainer fit Previous primary outcome measure: Bacterial count of Mutans Streptococci (MS) measured using colony counting method at retainer fit, 3 months and 6 months post retainer fit |
| Secondary outcome measures | Current secondary outcome measures as of 23/02/2022: 1. Saliva parameters (hydration, viscosity, pH and quantity) during retention measured using time and visual assessment of the transparency, volume and pH test strip indicator at retainer fit, 6, and 12 months post retainer fit 2. Patient-reported outcome measured using assessment form at 6 and 12 months post retainer fit Previous secondary outcome measures: 1. Saliva parameters (hydration, viscosity, pH and quantity) during retention measured using time and visual assessment of the transparency, volume and pH test strip indicator at retainer fit, 3 months and 6 months post retainer fit 2. Patient-reported outcome measured using assessment form at 3 months and 6 months post retainer fit |
| Overall study start date | 27/09/2019 |
| Overall study end date | 28/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 33 |
| Participant inclusion criteria | 1. Patients fitted with thermoplastic retainer 2. Over 18 years old 3. Caries free 4. Healthy periodontal status |
| Participant exclusion criteria | 1. Pregnant 2. Patients on medication 3. Smokers 4. Patients with systematic disease 5. Prosthetic tooth in retainer |
| Recruitment start date | 18/01/2021 |
| Recruitment end date | 28/08/2021 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Faculty of Dentistry
Jalan Hospital
Sungai Buloh
47000
Malaysia
Sponsor information
University/education
Faculty of Dentistry
Sungai Buloh Campus
Shah Alam
40450
Malaysia
| Phone | +60 (0)361265000 |
|---|---|
| recsecretariat@uitm.edu.my | |
| Website | http://www.uitm.edu.my/index.php/en |
"ROR" |
https://ror.org/05n8tts92 |
Funders
Funder type
University/education
Private sector organisation / Research institutes and centers
- Alternative name(s)
- Institute of Research Management & Innovation, IRMI, UiTM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 28/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Editorial Notes
18/04/2024: The intention to publish date was changed from 28/04/2024 to 28/04/2025.
16/02/2023: The intention to publish date was changed from 28/02/2023 to 28/04/2024.
24/11/2022: The following changes have been made:
1. The final enrolment number has been added.
2. The intention to publish date has been changed from 28/11/2022 to 28/02/2023.
23/02/2022: The following changes have been made:
1. The overall trial end date has been changed from 28/02/2022 to 28/12/2022.
2. The intervention has been updated.
3. The primary outcome measure has been updated.
4. The secondary outcome measures have been updated.
5. The plain English summary has been updated
23/08/2021: Internal review.
12/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/05/2021 to 28/08/2021.
2. The overall end date was changed from 28/11/2021 to 28/02/2022.
3. The plain English summary was updated to reflect these changes.
12/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/03/2021 to 28/05/2021.
2. The overall trial end date was changed from 31/08/2021 to 28/11/2021.
3. The intention to publish date was changed from 31/08/2022 to 28/11/2022.
24/12/2020: The following changes have been made:
1. Another scientific contact has been added.
2. The recruitment start date has been changed from 15/11/2020 to 18/01/2021.
3. The recruitment end date has been changed from 15/02/2021 to 15/03/2021.
06/11/2020: Uploaded protocol (not peer reviewed) Version n/a, 20 October 2020.
23/10/2020: Trial's existence confirmed by UiTM Research Ethics Committee.
